MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SKYRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432915

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Fracture, Arm (2351)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

The system has been checked by a siemens service engineer and found to be operating within specification.Furthermore, the siemens service engineer advised the operator to move the table while checking the patient's condition and recommended using the stop button in an emergency.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom skyra system.A patient with paralysis in the arm was examined.When pulling the table out from the magnet, the patient's left elbow became stuck.The table continued to be pulled from the magnet and the patient's left elbow hit the surface of the head coil cover resulting in a dislocation and fracture to the shoulder.No further information regarding medical intervention was provided by the hospital.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be user error.The system was checked by siemens service and found to be operating within specification.No hardware problem was found which would explain the reported fracture to the patient's shoulder.The service engineer advised the operator to move the table while checking the patient's condition and recommended using the stop button in an emergency.The root cause for the fracture is a direct skin-to-cover contact of the left elbow to the magnet bore wall.This represents an inadequate or incorrect positioning as described in the magnetom operator manual* on chapter 2 "safety", page15 and pages 20 and 21.Please always follow the instructions given in the operator manual, regarding correct patient positioning in order to avoid such incidents in the future.- always position the patient so that the patient's arms are aligned with the torso and ensure that hands, arms, and legs do not touch (minimum distance: 5 mm).- ensure that the minimum distance of 5 mm is maintained between patient and tunnel covering.- to ensure this distance, use positioning aids, e.G.Blankets made of linen, cotton, or paper, or dry material that is permeable to air.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8682257
• MDR Text Key: 147440704
• Report Number: 3002808157-2019-82853
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other